三七伤药片混合工艺优化试验研究

Optimization of Mixing Technology of Sanqi Shangyao Tablet

目的:三七伤药片中有4种药材原粉入药,占比43%,富粉性片剂,其中的雪上一枝蒿为毒性药材,服用限量70 mg,易发生中毒反应。冰片含量小,易升华,对肠胃有刺激作用。试验为提高混合均一性和稳定性,应用提高原粉粒度等方法对混合工艺进行优化。方法:以三七总皂苷为考查指标,以粒度、转数、混合时间为影响因素,考察均一性和批混时间终点,通过正交试验优化确定相关生产工艺参数。结果:原粉粒度100目、转数30 r/min、粉膏混合45分钟、批混30分钟条件下,经验证三七总皂苷含量可以控制在0.95~1.05 mg/片范围内,证明混合均匀性最佳。结论:提高原粉粒度,设定准确的转数与粉膏混合、批混时间,能有效提高三七伤药片均一性,进而确保产品质量。对类似富粉性中药片剂解决包衣质量问题,有借鉴意义。

Objective: There are 4 medicinal herbs that are powdered in Sanqi Shangyao tablet, and it is about 43% powder tablet. Aconitum brachypodum Deils is from the roots of several different Aconitum origins, and it is a toxic drug with a limited dose of 70 mg. A small amount of borneol is easy to subli-mate, and then stimulates stomach. In order to improve the uniformity and stability of mixing, the mixing process was optimized by improving the particle size of raw powder. Methods: The content of Panax Notoginseng Saponins (PNS) was used as the index, and the influence factors such as particle size, rotation, mixing time were considered, to investigate the endpoint of homogeneity and batch mixing through orthogonal test to determine the relevant production process parameters. Results: Under the conditions of 100 particle size of powder, 30 r/min, 45 min powder-ointment extracted mixing and 30 min batch mixing, the content of PNS is at the highest level at 0.95~1.05 mg/T and mixing well. Conclusion: Improving the particle size of raw powder, and setting exact rate and time in mixing powder with ointment extracted and in batch mixing, could effectively improve the uniformity of Sanqi Shangyao tablet, then to ensure its quality. This provides a solution to solve the problem of coating quality for similar powder-rich Chinese medicine tablets.